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AEVI-007 · 1 trial · 1 indication
Identify the recommended Phase 2 dose based on safety, pharmacokinetics and pharmacodynamics observed in this Phase 1b study.
| Arm | Type | Description |
|---|---|---|
| AEVI-007 | EXPERIMENTAL | Open-label, dose-escalation, single-arm |
| Name | Type | Description |
|---|---|---|
| AEVI-007 | DRUG | 50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection. |
Inclusion Criteria: 1. Subject has active R/R multiple myeloma. 2. Subject has measurable myeloma based on any of the following: * Serum M-protein \> 0.5 g/dL * Urine M-protein \> 200 mg/24 hours * Serum free light chains \> 10 mg/dL * Measurable plasmacytoma or extramedullary disease ...
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AEVI-007 is an investigational small molecule being studied for the treatment of relapsed or refractory multiple myeloma. It was evaluated in a Phase 1b clinical trial in adults with this cancer. It is not an approved therapy and remains in clinical development.
AEVI-007 targets interleukin-18, or IL-18, a cytokine. By acting on this cytokine target, the small molecule is designed to influence IL-18 mediated biology in multiple myeloma. IL-18 is a signaling protein involved in immune and inflammatory pathways.
AEVI-007 is being developed by Avalo Therapeutics, Inc., which trades on the Nasdaq under the ticker AVTX. The company sponsored the Phase 1b study of the drug in relapsed or refractory multiple myeloma conducted in the United States.
AEVI-007 is in Phase 1 development. A Phase 1b study in relapsed or refractory multiple myeloma has been completed, and no active trials of AEVI-007 are currently listed. The drug is investigational and has not been approved by the FDA.
AEVI-007 was studied in one clinical trial, NCT04671251, titled Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma. That trial is completed, enrolled 13 participants, was uncontrolled, and was conducted in the United States in adults aged 18 years and older.